- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801045
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In previous quantitative studies about the effect of an art therapy intervention in adult cancer inpatients of the Palliative Care Unit, the investigators evidenced significant improvements in the symptom control of malaise, anxiety, depression and pain.
This study is designed to deepen the understanding of specific action mechanisms which lead to those therapeutic benefits and quality of life implications for patients with life-threatening illness in which a situation of suffering is frequently detected.
The investigators will determine from the subjective patient's experience which specific elements of the artistic creative process (including production of art and art products) may lead to changes in the symptom perception, in meaning and healing process and in the personal perspective about the end of life situation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08025
- Hospital Sant Pau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- advanced-cancer adult inpatients of the Palliative Care Unit
- informed consent
Exclusion Criteria:
- altered cognitive function (Mini-Mental Test < 24)
- physical decline (palliative care team's criteria) that impedes the art therapy process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: art therapy
Individual 30-60 minutes art therapy sessions, twice a week, offering visual arts materials.
|
Patient's creativity is stimulated by visual arts materials and various art therapy techniques including punctual use of music, poetry and body expression. The intervention, based on the investigators previous experience, is founded on:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reflect Interview (RI) using audio recording.
Time Frame: After the making of a minimum of 5 art pieces, an average of 2 weeks
|
An art based interview is administered and involves the patients selecting 2 significant artworks from their art therapy productions.
The patient is asked by the art therapist for a narrative of how one artwork relates to the other in the context of his/her lived experience.
The art therapy dialogue from the RI is transcribed and subjected to thematic analysis.
|
After the making of a minimum of 5 art pieces, an average of 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Art therapy process from the art therapist perspective.
Time Frame: Every day of art therapy session, with an average of 2 sessions a week, over a period of 2 years.
|
Detailed notes and photographical register.
|
Every day of art therapy session, with an average of 2 sessions a week, over a period of 2 years.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Pascual, MD, Palliative Care Unit, Sant Pau Hospital, Barcelona, Spain.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-ART-2016-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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